- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07606222
Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection
2026년 5월 17일 업데이트: Amr Mohamed Sabry Lotfi Amer, Cairo University
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.
연구 개요
상태
완전한
정황
상세 설명
Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy.
Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements.
Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy.
There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.
연구 유형
중재적
등록 (실제)
45
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Alexandria, 이집트
- Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 6-14 years post brain tumor surgery children.
- Children's hand use experience questionnaire between 25 and 50 on a scale of units.
- Grade 2 muscle power of wrist, elbow and finger extensors.
- Outpatient children.
- Post-operative brain tumour, which is located in one of the two hemispheres.
- After 6 weeks post-surgery.
- The child can follow orders and instructions.
Exclusion Criteria:
- Blindness.
- Deaf child.
- Skin diseases.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: selected physical therapy program
The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.
|
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
|
|
실험적: selected physical therapy program and biofeedback
Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program.
|
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm.
The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction.
Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
|
|
실험적: selected physical therapy program and neuromuscular electric stimulation
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.
|
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm.
The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction.
Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessment of muscle activity
기간: at baseline and after 12 weeks
|
All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes.
The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally.
After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.
|
at baseline and after 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessment of upper limb function
기간: at baseline and after 12 weeks
|
Using the short form of the Bruininks-Oseretsky Test, which includes fourteen selected test items, subtests 1, 2, 3, 4, and 7 are administered.
The child is positioned sitting at a table.
The time taken for each task is noted as part of the proficiency evaluation.
Performance is recorded, and raw scores are converted to point scores using a conversion table.
The better result from two trials for each item is taken, and the total points from the fourteen short items are recorded in the designated area.
|
at baseline and after 12 weeks
|
|
assessment of level of neurotrophic factor
기간: at baseline and after 12 weeks
|
Fasting blood samples were taken in potassium-methylene diamine tetra acetic acid tubes, centrifuged for 15 minutes at 3000 rpm, and the plasma was stored at -80°C before being sent to Myriad RBM for a 190-analyte multiplex immunoassay.
Additionally, the Brain-derived neurotrophic factor enzyme-linked immunosorbent assay reliably measures whole blood Brain-derived neurotrophic factor with high reproducibility.
|
at baseline and after 12 weeks
|
|
assessment of dynamic spasticity of wrist and elbow flexors muscles
기간: at baseline and after 12 weeks
|
Dynamic spasticity of wrist and elbow flexors muscles will be analyzed at the study's start and end.
Measurements will include resistance 1 (fast velocity movement through full range of motion to identify the point of catch), resistance 2 (passive range of motion), and the difference resistance 2-resistance 1 (dynamic spasticity component).
The Modified Ashworth Scale serves as a clinical tool for assessing spasticity, employing quantitative measurements at two speeds: slow (resistance 2) and fast (resistance 1).
|
at baseline and after 12 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 7월 1일
기본 완료 (실제)
2025년 6월 1일
연구 완료 (실제)
2025년 9월 1일
연구 등록 날짜
최초 제출
2026년 5월 17일
QC 기준을 충족하는 최초 제출
2026년 5월 17일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 17일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Amr-phd
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .